October 2018

Chief medical editor’s corner of the worldThe system works

“The system worked because the FDA asked for the correct information and follow-up. The system also worked because we expect transparency and honesty from the companies we work with.”

On August 29, 2018, Alcon (Fort Worth, Texas) issued a voluntary global recall of the CyPass Micro-Stent, a suprachoroidal MIGS device for the surgical treatment of glaucoma. The announcement came after post-approval studies conducted by Alcon, per the U.S. Food and Drug Administration (FDA), detected an increase in endothelial cell loss among patients who received the CyPass during cataract surgery 5 years earlier compared with patients who underwent cataract surgery alone. The action was swift and decisive. The initial impression by many was, “What went wrong?” At face value this seems a reasonable response. It’s human nature to find a scapegoat when we face a problem so we can place blame. In reality, we should acknowledge—if not celebrate—the fact that in this case, the system worked.
Innovation requires testing new treatments, evaluating their efficacy, and following them for both short-term and long-term safety. The initial COMPASS trial was a 24-month study and evaluated 505 CyPass patients in 24 centers. It was a well-designed and thorough trial, and showed both safety and efficacy. Too often the FDA is chastised for delaying approval of devices while our colleagues in other parts of the world have the opportunity to work with new technology. In the case of the CyPass, the FDA asked for a very reasonable 2-year follow-up prior to approval, then mandated that Alcon study the same patients for an additional 3 years to confirm safety. The 5-year safety study showed endothelial cell loss that was highly associated with the placement of the device and not seen in the 2-year results. When correctly placed, the endothelial cell loss was greater than in the control, but not worrisome When the device was more exposed in the anterior chamber, the cell loss was greater.
Innovation is the backbone of all of medicine, especially in ophthalmology. New treatments are developed, and patients benefit from them. At the same time, it is unrealistic to expect that every innovation will be without setbacks. As clinicians and representatives of our patients, we ask that new devices and medications be evaluated carefully but also approved in a reasonable time period. Overwhelmingly a 2-year study provides this reassurance, but a 3-year post-approval surveillance trial provides additional certainty.
The system worked because the FDA asked for the correct information and follow-up. The system also worked because we expect transparency and honesty from the companies we work with. In this case, as soon as the data became available, Alcon took swift and decisive action. Stephen Lane, MD, Alcon’s chief medical officer, stated in a company press release, “Based on this new information, we are advising surgeons to immediately cease further implants with the CyPass microstent” and that this was, “in the patients’ best interest and is the right thing to do.”
Now we have to decide how to manage these patients. These decisions should be made by the best clinicians—not the FDA or industry. As you’ll see on pages 16–17 of this issue, a task force of ASCRS Glaucoma and Cornea Clinical Committee members have worked together to create an independent physician guidance document for how these patients should be managed moving forward. The FDA, Alcon, and ASCRS have worked together seamlessly to promote innovation and protect patients, and I say, “Job well done.”